Not specified (note: this could be clarified as "hybrid" based on common industry practices, but it's not explicitly stated in the job description.)
Aseptic filling experience required
New dp facility startup readiness
Gmp standards knowledge iso en ich fda ispe
Roche is seeking a Senior Specialist in QV Biologics for their Shanghai location, focusing on qualification and validation activities in compliance with regulatory standards. The candidate should have a background in pharmaceutical or biotechnology QA/QV, with specific experience in aseptic filling and facility startup
Job Summary
The role involves overseeing qualification and validation activities to ensure compliance with Roche Standards, Good Practices, and regulatory requirements.
Candidates must possess sound knowledge of current GMP standards related to equipment, utilities, and facilities commissioning for new drug product facilities.
The position requires collaboration with cross-functional teams including Project, F&E, MSAT, Manufacturing, and QC to address quality issues and support lean initiatives.
Matching Summary
Match Score: 85
Roche is seeking a Senior Specialist in QV Biologics for their Shanghai location, focusing on qualification and validation activities in compliance with regulatory standards. The candidate should have a background in pharmaceutical or biotechnology QA/QV, with specific experience in aseptic filling and facility startup.
Skills & Requirements
Must-have
Aseptic Filling experience required
New DP facility startup readiness
GMP standards knowledge ISO EN ICH FDA ISPE
Qualification validation URS FAT SAT IQ OQ PQ
Project CSV Data Integrity C&Q strategy
Nice-to-have
Lean initiatives support
Auditor training certification
Project management skills preferred
Multinational company experience
Strong technical writing ability
Key Requirements
MSc or experienced BSc in (Bio) chemical Engineering, Biochemistry, Applied Science
Minimum 3 years experience in pharmaceutical or biotechnology QA/QV
Fluent oral and written English communication skills